Drugs

Novo Nordisk Asks Liraglutide Drug ANDA Restrictions

Novo Nordisk is asking FDA not to approve any ANDA referencing any of the company’s liraglutide-containing drugs as the reference-listed drug. The company’s 10/2 petition also asks that the agency:

not approve any 505(b)(2) NDA that references any of the company’s liraglutide-containing drugs unless and until the sponsor provides data from clinical comparative studies sufficient to establish that it is appropriate for FDA to rely on the agency’s findings of safety and effectiveness for the Novo Nordisk drug;
issue guidance with “suitably stringent standards, as detailed in this petition, for assessing whether a follow-on liraglutide product, whether synthetic or recombinant-derived, is sufficiently similar to Novo Nordisk’s liraglutide to justify reliance on FDA’s prior findings of safety and effectiveness;” and
consider issues raised in the petition in developing guidance for and reviewing applications for follow-on versions of other polypeptide and complex polypeptide drugs.

Novo Nordisk identifies the drugs in question as Victoza (liraglutide) injection, Saxenda (liraglutide) injection, or Xultophy (insulin degludec and liraglutide injection). It says the petition provides data and information supporting that liraglutide is a complex molecule whose efficacy and safety are specifically tied to the manufacturing process. “Variations in manufacturing process that result from a different manufacturer producing a synthetic follow-on product or a recombinant follow-on product may significantly alter the function of the product, and may potentially result in adverse clinical consequences,” the petition says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome